Senior Director, Regulatory Affairs & Strategic Consulting
Ben Kaspar, Senior Director, Regulatory Affairs & Strategic Consulting, oversees the Regulatory strategy consulting team.
Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life-cycle. Ben and team have a deep experience in regulatory science for drug/biologic development, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas including rare diseases.
Ben and the MMS strategists can also adapt regional strategies to meet the needs of a global development plan, reflecting applicable domestic and international requirements, working with regionally based representatives as needed to achieve the sponsor’s ambitions. Facilitating all interactions with regulatory agencies including major Health Authority interactions including FDA advisory committee meetings, Scientific Advice, Pre-IND/CTA, Pre-NDA/BLA, EOP2 meetings and others that may be required to meet the needs of the program.
With a unique combination of strategic expertise and submissions best practices, Ben and team have been responsible for numerous Investigational New Drug Applications (INDs), multiple Orphan Drug Designation (ODD) applications, breakthrough designation applications, special protocol assessments, fast track applications and an average of 10 New Drug Applications each year. Ben and the MMS regulatory leaders are accountable for the effective planning and organization of all dossier components working hand-in-hand with regulatory operations. Ben’s expertise also extends to process best practices for content development serving as an expert advisor in all areas of writing including briefing books and summary documents.
Ben is a graduate of Case Western Reserve University with a master’s degree in Biochemistry. He has been with MMS for 13 years.